Background:Plate osteosynthesis (referred to throughout as plating) and intramedullary nailing (referred to throughout as nailing) are the most common operative strategies for humeral shaft... Show moreBackground:Plate osteosynthesis (referred to throughout as plating) and intramedullary nailing (referred to throughout as nailing) are the most common operative strategies for humeral shaft fractures. However, it is undecided which treatment is more effective. This study aimed to compare functional and clinical outcomes of these treatment strategies. We hypothesized that plating would result in an earlier recovery of shoulder function and fewer complications.Methods:From October 23, 2012, to October 3, 2018, adults with a humeral shaft fracture, OTA/AO type 12A or 12B, were enrolled in a multicenter, prospective cohort study. Patients were treated with plating or nailing. Outcome measures included the Disabilities of the Arm, Shoulder and Hand (DASH) score, Constant-Murley score, ranges of motion of the shoulder and elbow, radiographic healing, and complications until 1 year. Repeated-measure analysis was done with correction for age, sex, and fracture type.Results:Of the 245 included patients, 76 were treated with plating and 169 were treated with nailing. Patients in the plating group were younger, with a median age of 43 years compared with 57 years for the nailing group (p < 0.001). The mean DASH score after plating improved faster over time, but did not differ significantly from the score after nailing at 12 months (11.7 points [95% confidence interval (CI), 7.6 to 15.7 points]) for plating and 11.2 points [95% CI, 8.3 to 14.0 points] for nailing). The Constant-Murley score and shoulder abduction, flexion, external rotation, and internal rotation displayed a significant treatment effect (p(treatment) & LE; 0.001), in favor of plating. The plating group had 2 implant-related complications, whereas the nailing group had 24, including 13 nail protrusions and 8 screw protrusions. Plating resulted in more postoperative temporary radial nerve palsy (8 patients [10.5%] compared with 1 patient [0.6%]; p < 0.001) and a trend toward fewer nonunions (3 patients [5.7%] compared with 16 patients [11.9%]; p = 0.285) than nailing.Conclusions:Plating of a humeral shaft fracture in adults results in faster recovery, especially of shoulder function. Plating was associated with more temporary nerve palsies, but fewer implant-related complications and surgical reinterventions, than nailing. Despite heterogeneity in implants and surgical approach, plating seems to be the preferred treatment option for these fractures. Show less
Background The Netherlands Armed Forces have been successfully using deep-frozen (- 80 degrees C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere... Show moreBackground The Netherlands Armed Forces have been successfully using deep-frozen (- 80 degrees C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for the effectiveness and safety of DTCs is currently lacking. Therefore, the MAssive transfusion of Frozen bloOD (MAFOD) trial is designed to compare the haemostatic effect of DTCs versus room temperature-stored platelets (RSP) in the treatment of surgical bleeding. Methods The MAFOD trial is a single-blinded, randomized controlled non-inferiority trial and will be conducted in three level 1 trauma centres in The Netherlands. Patients 12 years or older, alive at hospital presentation, requiring a massive transfusion including platelets and with signed (deferred) consent will be included. The primary outcome is the percentage of patients that have achieved haemostasis within 6 h and show signs of life. Haemostasis is defined as the time in minutes from arrival to the time of the last blood component transfusion (plasma/platelets or red blood cells), followed by a 2-h transfusion-free period. This is the first randomized controlled study investigating DTCs in trauma and vascular surgical bleeding. Discussion The hypothesis is that the percentage of patients that will achieve haemostasis in the DTC group is at least equal to the RSP group (85%). With a power of 80%, a significance level of 5% and a non-inferiority limit of 15%, a total of 71 patients in each arm are required, thus resulting in a total of 158 patients, including a 10% refusal rate. The data collected during the study could help improve the use of platelets during resuscitation management. If proven non-inferior in civilian settings, frozen platelets may be used in the future to optimize logistics and improve platelet availability in rural or remote areas for the treatment of (massive) bleeding trauma patients in civilian settings. Show less
Loggers, S.A.I.; Willems, H.C.; Balen, R. van; Gosens, T.; Polinder, S.; Ponsen, K.J.; ... ; FRAIL-HIP Study Grp 2022
IMPORTANCE Decision-making on management of proximal femoral fractures in frail patients with limited life expectancy is challenging, but surgical overtreatment needs to be prevented. Current... Show moreIMPORTANCE Decision-making on management of proximal femoral fractures in frail patients with limited life expectancy is challenging, but surgical overtreatment needs to be prevented. Current literature provides limited insight into the true outcomes of nonoperative management and operative management in this patient population. OBJECTIVE To investigate the outcomes of nonoperative management vs operative management of proximal femoral fractures in institutionalized frail older patients with limited life expectancy. DESIGN, SETTING, AND PARTICIPANTS This multicenter cohort studywas conducted between September 1, 2018, and April 25, 2020, with a 6-month follow-up period at 25 hospitals across the Netherlands. Eligible patientswere aged 70 years or older, frail, and institutionalized and sustained a femoral neck or pertrochanteric fracture. The term frail implied at least 1 of the following characteristicswas present: malnutrition (body mass index [calculated asweight in kilograms divided by height in meters squared] <18.5) or cachexia, severe comorbidities (American Society of Anesthesiologists physical status class of IV or V), or severe mobility issues (Functional Ambulation Category similar to 2). EXPOSURES Shared decision-making (SDM) followed by nonoperative or operative fracture management. MAIN OUTCOMES AND MEASURES The primary outcomewas the EuroQol 5 Dimension 5 Level (EQ-5D) utility score by proxies and caregivers. Secondary outcome measures were QUALIDEM (a dementia-specific quality-of-life instrument for persons with dementia in residential settings) scores, pain level (assessed by the Pain Assessment Checklist for Seniors With Limited Ability to Communicate), adverse events (Clavien-Dindo classification), mortality, treatment satisfaction (numeric rating scale), and quality of dying (Quality of Dying and Death Questionnaire). RESULTS Of the 172 enrolled patients with proximal femoral fractures (median [25th and 75th percentile] age, 88 [85-92] years; 135women [78%]), 88 opted for nonoperative management and 84 opted for operative management. The EQ-5D utility scores by proxies and caregivers in the nonoperative management group remained within the set 0.15 noninferiority limit of the operative management group (week 1: 0.17 [95% CI, 0.13-0.29] vs 0.26 [95% CI, 0.11-0.23]; week 2: 0.19 [95% CI, 0.10-0.27] vs 0.28 [95% CI, 0.22-0.35]; and week 4: 0.24 [95% CI, 0.15-0.33] vs 0.34 [95% CI, 0.28-0.41]). Adverse eventswere less frequent in the nonoperative management group vs the operative management group (67 vs 167). The 30-day mortality rate was 83%(n = 73) in the nonoperative management group and 25%(n = 21) in the operative management group, with 26 proxies and caregivers (51%) in the nonoperative management group rating the quality of dying as good-almost perfect. Treatment satisfaction was high in both groups, with a median numeric rating scale score of 8. CONCLUSIONS AND RELEVANCE Results of this study indicated that nonoperative management of proximal femoral fractures (selected through an SDM process) was a viable option for frail institutionalized patients with limited life expectancy, suggesting that surgery should not be a foregone conclusion for this patient population. Show less
Purpose: The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in... Show morePurpose: The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery. Methods: From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant-Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type. Results: Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant-Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001). Conclusion: Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group. Show less
Introduction The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization... Show moreIntroduction The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs. Materials and methods This study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat. Results There were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were euro3624 in the early mobilization group versus euro7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (euro1719 in the early mobilization group versus euro4589; p = 0.120). Conclusion From a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost. Show less
